One-Lung Ventilation in the Morbidly Obese Patient: Comparison of Double Lumen Versus Bronchial Blockers

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: Double Lumen Endotracheal Tube; Device: Arndt Bronchial Blocker

• Registration Number: NCT00813176
• Lead Sponsor: Javier H Campos

Brief Summary

The purpose of this study is to determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery.

Detailed Description

The purpose of the study is to compare a double lumen tube versus the standard single-lumen tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung ventilation during surgery. The objects is to determine which device is best for intubation and is most effective in terms of optimal positioning of the device, of lung collapse, and quality of lung isolation.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Results First Submitted: 2017-07-06
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-01
• Last Update Submitted: 2018-05-01
• Results First Posted: 2018-06-04
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
2. Subject is >18 years of age.
3. Subject's BMI > 35.

Exclusion Criteria

1. Subject < 18 years of age.
2. Subject's BMI < 35.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Lumen Endotracheal Tube	Double Lumen Endotracheal Tube	We used a device called a double lumen tube ( DLT Broncho-Cath®). It is a bifurcated endotracheal tube designed to independently collapse the operated lung.
Arndt Bronchial Blocker	Arndt Bronchial Blocker	We used a device called a bronchial blocker (9 Fr Arndt® blocker) along with a standard single-lumen tracheal tube (8.0-9.0 mm ID). The Arndt bronchial blocker is a single device, with a distal balloon that is passed thru the single lumen endotracheal once the patient is intubated. The Arndt bronchial blocker is designed to collapse the operated lung.

Primary Outcome Measures

Name	Time	Method
Number of Participants in Which the Tube Was Successfully Positioned at First Attempt	This data measure was occurred during surgery.	Number of participants in each group in which the tube was successfully positioned at first attempt
Time Taken for Endotracheal Tube Placement Procedure.	This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.	For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube.; Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Successful Reinflation	This occurred during surgery.	In each group, the number of Participants in which successful lung reinflation occurred.
Effectiveness of Lung Collapse	This measure occured during surgery just after intubation.	For each group, the number of participants in which lung collapse was evaluated as: (i) good-complete collapse without surgical interference, (ii) fair-total collapse, but with residual air, and (iii) poor-no or partial collapse, lung inflated and interfering with the surgical exposure.
Time Required to Collapse the Lung	This measurement occurred during surgery.	For each group, the mean time for lung isolation/collapse was measured from the institution of one-lung ventilation to the time of total lung collapse.
Mean Intraoperative Oxygenation During One-lung Ventilation	This measure occured during surgery.	For each group, the mean intraoperative oxygenation (arterial partial pressure of oxygen measured by arterial blood gases) were taken during two-lung ventilation (baseline) and after 30 min of one-lung ventilation.

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States